Venous Ulcers Skin and Connective Tissue Diseases
Conditions
Interventions
Patients will be divided in 2 arms: arm A patients will be treated daily with Bionect Start plus compression therapy, arm B patients will be treated daily with placebo plus compression therapy
Sponsors
Fidia Pharmaceuticals (Fidia Farmaceutici S.p.A.) (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both sexes, all ethnic backgrounds, both ambulatory and hospitalized Subjects, between 18 and 80 years of age 2. Subjects with a diagnosis of chronic venous ulcers (CEAP classification: C6) with devitalized/fibrinous/slough tissue more than 40% of the lesion. Chronic ulcer is defined as that ulcer not reducing its area of at least 20-40% in 4 weeks of optimum treatment (i.e. compession bandaging/stocking). 3. Subjects who have a venous leg ulcer of at least 6 months duration 4. Subjects who have a target wound which is between 5 cm squared to 30 cm squared in area at the baseline assessment 5. Subjects, who are, in the opinion of the Investigator, able to understand this study, cooperate with the study procedures and are willing to return to the center for all the required visits 6. Subjects who have given their written informed consent in accordance with provisions of pertinent excerpt from the Declaration of Helsinki (revised October 2008) and GCP for medical devices
Exclusion criteria
Exclusion criteria: 1. Subjects who have exposed bone, tendon or fascia visible around the target wound 2. Subjects who have an Ankle Brachial Pressure Index lower than 0.8 (ABPI 35), cachexia and recent burns 8. Participation in any other study involving investigational or marketed products concomitantly or within one month prior to study entrance 9. A history of alcoholism, treatment abuse, psychological or other emotional problems that could invalidate informed consent or limit the Subject compliance with protocol requirements. 10. Females who are pregnant, lactating or who have not reached menopause and are not abstinent or practising an acceptable means of birth control as determined by the Investigator for the duration of the study 11. Necessity to have a concomitant therapy with any treatment mentioned in the restrictions 12. Subjects unlikely to be compliant/cooperative during the study, in the judgment of the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean of debridement rate (in terms of percentage change of devitalized/fibrinous/slough tissue area) measured by digital planimetry system at Day 15. For patients with a complete debridement occurring before Day 15 will be assigned a debridement value equal to 100%. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following variables will be evaluated at baseline and at each subsequent visit: 1. Mean of debridement rate measured by digital planimetry system 2. Pain during the day assessed by VAS scale 3. Pain during the night assessed by VAS scale 4. Pain during the change of dressing medication assessed by VAS scale 5. Wound size at each visit. The mean change (%) in wound size will be measured by digital planimetry system 6. Odour 7. Tissue viability 8. Erythema/redness in periwound skin 9. The following will be evaluated at last visit: 10. Investigator?s global assessment of wound bed 11. Investigator?s global assessment of dressing comfort 12. Quality of life by EQ-5D will be assessed at baseline visit and final visit 13. For all the duration of the study safety and tolerability will be assessed by recording all AE | — |
Countries
Italy
Outcome results
None listed